HypotensionPhase 2/3NCT01414777
Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients
A Phase 2/3 study testing ondansetron in people with Hypotension and Pregnancy, run by University of Virginia at 1 site in United States.
Trial summary
The investigators hypothesize that given prophylactically, intravenous ondansetron will attenuate the drop in blood pressure and heart rate frequently seen after spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypotension, Pregnancy
- What is being tested?
- ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jun 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Elective Caesarean section
- Consent to be in the study
- Age 18-45
- ASA 1 or 2
Who cannot join
- Patient refusal
- Patients with known allergy to ondansetron will be excluded
- Contraindications to spinal anesthetic
- Known Coagulopathy (acquired e.g. anticoagulation or existing such as liver disease; using patient history, physical examination to determine bleeding risks, a platelet count under 100 or a PT INR over 1.4)
- Severely altered anatomy (e.g. post surgical changes)
- Existing neurological deficits (Women with a history of migraine or tension headache will be allowed to enroll. More severe conditions with daily life limiting symptoms will be excluded. Examples include epilepsy, pseudotumor cerebri, prior stroke with persistent neurologic deficits, or any motor or sensory neuropathy with existing deficits)
- Skin infection overlying site
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: IRB-HSR# 14583: Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients
The investigators hypothesize that given prophylactically, intravenous ondansetron will attenuate the drop in blood pressure and heart rate frequently seen after spinal anesthesia.
Eighty-six American Society of Anesthesiologists (ASA) physical status I or II in preoperative patient assessment, parturients age of 18 to 45 years scheduled to undergo elective caesarean section will be enrolled.
Read more
Patients will be randomized to 2 groups: the ondansetron group, receiving 8 mg intravenous ondansetron diluted in 10 mL of saline; or the placebo group, who were administered 10 mL of saline given 5 minutes prior to performing the spinal anesthetic. Investigational Pharmacy will randomize and dispense study drug.
Baseline measurements of vital signs will be taken. Otherwise standard management will then be used:
- Patients must be NPO for 8 hours
- Pulse oximetry, EKG monitoring, noninvasive blood pressure at a minimum of every 3 minutes, more frequently if decided by the provider.
- Standard lumbar puncture in a sitting position the L3-L4 or L4-L5
- Whitacre pencil-point, 25 gauge
- Injectate: 2 mL of 0.75% hyperbaric bupivacaine, 100 mcg preservative free morphine, 20 mcg fentanyl
- Immediately after completing the subarachnoid injection, patients will be laid supine with left lateral uterine displacement
The sensory level of anesthesia will be assessed in the standard fashion every five minutes using ice. The motor component will tested using the Bromage scale for spinal anesthesia (0, no paralysis; 1, inability to lift the thigh [only knee/feet]; 2, inability to flex the knee [only feet]; 3, inability to move any joint in the legs).
Read the detailed description
Over the last 30 years, regional anesthesia has emerged as the method of choice for elective caesarean section because it avoids risks involved in managing the airway of the parturient and has the added significant benefit of mother being awake for the birth of her child. Indeed, this changing practice patterns is thought to have lead to a significant drop in anesthesia related maternal morbidity and mortality.
At the same time, regional anesthesia is associated with both minor and significant risk.
Most common among these effects is hypotension and bradycardia, occurring in 33% and 13% of cases, respectively. In the pregnant patient, supine positioning required for surgery is associated hypotension due to aortocaval compression by the gravid uterus in 8% of patients, even without spinal anesthesia. During caesarean section, the combination of these factors can lead to hypotension include decreased placental blood flow, impaired fetal oxygenation and fetal acidosis. Maternal symptoms of low blood pressures include nausea, vomiting, dizziness, and decreased consciousness. This situation has lead to dozens of publications seeking to prevent or minimize the hypotensive response.
Hypotension after a spinal is initially due to a blockade of sympathetic fibers leading to a drop in systemic vascular resistance. Spinal-induced bradycardia is multifactorial but is in part due to the Bezold-Jarisch Reflex (BJR). This reflex is mediated by serotonin receptors within the wall of the ventricle in response to systemic hypotension. These receptors, the 5HT3 subtype, cause an increase efferent vagal signaling when bound by serotonin released during hypovolemic states, clinically leading to bradycardia and further hypotension.
Ondansetron, a widely used anti-emetic and serotonin antagonist, has been safely used to blunt the BJR, resulting in less bradycardia and hypotension first in animals and later in humans undergoing spinal anesthesia. ,
Use During Pregnancy:
The FDA labels ondansetron as a class B. Studies in pregnant rats and rabbits at doses up to 70 times higher than clinically used doses revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, few prospective studies in pregnant women. Nevertheless, the drug is widely used has a long safety history for use in pregnancy and during anesthesia for caesarean section.
- Conditions
- Hypotension, Pregnancy
- Being tested
- ondansetron, placebo
- Keywords
- c-section, Hypotension after spinal anesthesia for C-section
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ondansetronDrug
Also called epidural
Ondansetron 8mg IV or placebo will be administered prior to placement of the spinal anesthetic
placeboDrug
Also called epidural
placebo or ondansetron 8mg IV will be administered prior to placement of the spinal anesthetic
| Study group | Role | What they receive |
|---|---|---|
| ondansetron | Experimental | ondansetron 8 mg IV will be administered prior to placement of the spinal anesthesia Receives: Drug: ondansetron |
| Placebo | Placebo comparator | Ondansetron 8 mg IV or Placebo will be administered prior to placement of the spinal anesthestic Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability"
hypotension \& bradycardia will be recorded from the placement of the spinal through the end of surgical c-section
Measured: day 1
Secondary outcomes (5)
dosage of vasopressors administered
vasopressors administered during surgery
Measured: day one
number of episodes of nausea
Measured: 24 hours after surgery
occurrence & intensity of itching
Measured: 24 hours after surgery
pain scores reported by the patient
Measured: 24 hours after surgery
dosage of anticholinergics administered
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Tiouririne, MD, University of Virginia
- Investigators
- Jordan Hackworth, MD, Principal investigator, University of Virginia Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414777
- Sponsor's protocol ID
- 14583
- Status last verified
- Mar 2022
- First submitted
- 16 Sep 2010
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Hawkins JL. Anesthesia-related maternal mortality. Clin Obstet Gynecol. 2003 Sep;46(3):679-87. doi: 10.1097/00003081-200309000-00020. No abstract available.
PubMed 12972749Mhyre JM, Riesner MN, Polley LS, Naughton NN. A series of anesthesia-related maternal deaths in Michigan, 1985-2003. Anesthesiology. 2007 Jun;106(6):1096-104. doi: 10.1097/01.anes.0000267592.34626.6b.
PubMed 17525583Lee LA, Posner KL, Domino KB, Caplan RA, Cheney FW. Injuries associated with regional anesthesia in the 1980s and 1990s: a closed claims analysis. Anesthesiology. 2004 Jul;101(1):143-52. doi: 10.1097/00000542-200407000-00023.
PubMed 15220784Liu SS, McDonald SB. Current issues in spinal anesthesia. Anesthesiology. 2001 May;94(5):888-906. doi: 10.1097/00000542-200105000-00030. No abstract available.
PubMed 11388543Jackson R, Reid JA, Thorburn J. Volume preloading is not essential to prevent spinal-induced hypotension at caesarean section. Br J Anaesth. 1995 Sep;75(3):262-5. doi: 10.1093/bja/75.3.262.
PubMed 7547039Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994 May;83(5 Pt 1):774-88.
PubMed 8164943Rout CC, Rocke DA. Prevention of hypotension following spinal anesthesia for cesarean section. Int Anesthesiol Clin. 1994 Spring;32(2):117-35. No abstract available.
PubMed 8063445Mathru M, Rao TL, Kartha RK, Shanmugham M, Jacobs HK. Intravenous albumin administration for prevention of spinal hypotension during cesarean section. Anesth Analg. 1980 Sep;59(9):655-8.
PubMed 7191222Dahlgren G, Granath F, Pregner K, Rosblad PG, Wessel H, Irestedt L. Colloid vs. crystalloid preloading to prevent maternal hypotension during spinal anesthesia for elective cesarean section. Acta Anaesthesiol Scand. 2005 Sep;49(8):1200-6. doi: 10.1111/j.1399-6576.2005.00730.x.
PubMed 16095463Ueyama H, He YL, Tanigami H, Mashimo T, Yoshiya I. Effects of crystalloid and colloid preload on blood volume in the parturient undergoing spinal anesthesia for elective Cesarean section. Anesthesiology. 1999 Dec;91(6):1571-6. doi: 10.1097/00000542-199912000-00006.
PubMed 10598596Riley ET, Cohen SE, Rubenstein AJ, Flanagan B. Prevention of hypotension after spinal anesthesia for cesarean section: six percent hetastarch versus lactated Ringer's solution. Anesth Analg. 1995 Oct;81(4):838-42. doi: 10.1097/00000539-199510000-00031.
PubMed 7574020Campagna JA, Carter C. Clinical relevance of the Bezold-Jarisch reflex. Anesthesiology. 2003 May;98(5):1250-60. doi: 10.1097/00000542-200305000-00030. No abstract available.
PubMed 12717149Villalon CM, Centurion D. Cardiovascular responses produced by 5-hydroxytriptamine:a pharmacological update on the receptors/mechanisms involved and therapeutic implications. Naunyn Schmiedebergs Arch Pharmacol. 2007 Oct;376(1-2):45-63. doi: 10.1007/s00210-007-0179-1. Epub 2007 Aug 17.
PubMed 17703282Veelken R, Sawin LL, DiBona GF. Epicardial serotonin receptors in circulatory control in conscious Sprague-Dawley rats. Am J Physiol. 1990 Feb;258(2 Pt 2):H466-72. doi: 10.1152/ajpheart.1990.258.2.H466.
PubMed 2309912Owczuk R, Wenski W, Polak-Krzeminska A, Twardowski P, Arszulowicz R, Dylczyk-Sommer A, Wujtewicz MA, Sawicka W, Morzuch E, Smietanski M, Wujtewicz M. Ondansetron given intravenously attenuates arterial blood pressure drop due to spinal anesthesia: a double-blind, placebo-controlled study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):332-9. doi: 10.1016/j.rapm.2008.01.010.
PubMed 18675744
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRB-HSR# 14583: Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients
- ClinicalTrials.gov ID
- NCT01414777
- Acronym / sponsor ID
- 14583
- Conditions
- Hypotension, Pregnancy
- Keywords
- c-section, Hypotension after spinal anesthesia for C-section
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that given prophylactically, intravenous ondansetron will attenuate the drop in blood pressure and heart rate frequently seen after spinal anesthesia.
Eighty-six American Society of Anesthesiologists (ASA) physical status I or II in preoperative patient assessment, parturients age of 18 to 45 years scheduled to undergo elective caesarean section will be enrolled.
Patients will be randomized to 2 groups: the ondansetron group, receiving 8 mg intravenous ondansetron diluted in 10 mL of saline; or the placebo group, who were administered 10 mL of saline given 5 minutes prior to performing the spinal anesthetic. Investigational Pharmacy will randomize and dispense study drug.
Baseline measurements of vital signs will be taken. Otherwise standard management will then be used:
- Patients must be NPO for 8 hours
- Pulse oximetry, EKG monitoring, noninvasive blood pressure at a minimum of every 3 minutes, more frequently if decided by the provider.
- Standard lumbar puncture in a sitting position the L3-L4 or L4-L5
- Whitacre pencil-point, 25 gauge
- Injectate: 2 mL of 0.75% hyperbaric bupivacaine, 100 mcg preservative free morphine, 20 mcg fentanyl
- Immediately after completing the subarachnoid injection, patients will be laid supine with left lateral uterine displacement
The sensory level of anesthesia will be assessed in the standard fashion every five minutes using ice. The motor component will tested using the Bromage scale for spinal anesthesia (0, no paralysis; 1, inability to lift the thigh [only knee/feet]; 2, inability to flex the knee [only feet]; 3, inability to move any joint in the legs).
Detailed description
Over the last 30 years, regional anesthesia has emerged as the method of choice for elective caesarean section because it avoids risks involved in managing the airway of the parturient and has the added significant benefit of mother being awake for the birth of her child. Indeed, this changing practice patterns is thought to have lead to a significant drop in anesthesia related maternal morbidity and mortality.
At the same time, regional anesthesia is associated with both minor and significant risk.
Most common among these effects is hypotension and bradycardia, occurring in 33% and 13% of cases, respectively. In the pregnant patient, supine positioning required for surgery is associated hypotension due to aortocaval compression by the gravid uterus in 8% of patients, even without spinal anesthesia. During caesarean section, the combination of these factors can lead to hypotension include decreased placental blood flow, impaired fetal oxygenation and fetal acidosis. Maternal symptoms of low blood pressures include nausea, vomiting, dizziness, and decreased consciousness. This situation has lead to dozens of publications seeking to prevent or minimize the hypotensive response.
Hypotension after a spinal is initially due to a blockade of sympathetic fibers leading to a drop in systemic vascular resistance. Spinal-induced bradycardia is multifactorial but is in part due to the Bezold-Jarisch Reflex (BJR). This reflex is mediated by serotonin receptors within the wall of the ventricle in response to systemic hypotension. These receptors, the 5HT3 subtype, cause an increase efferent vagal signaling when bound by serotonin released during hypovolemic states, clinically leading to bradycardia and further hypotension.
Ondansetron, a widely used anti-emetic and serotonin antagonist, has been safely used to blunt the BJR, resulting in less bradycardia and hypotension first in animals and later in humans undergoing spinal anesthesia. ,
Use During Pregnancy:
The FDA labels ondansetron as a class B. Studies in pregnant rats and rabbits at doses up to 70 times higher than clinically used doses revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, few prospective studies in pregnant women. Nevertheless, the drug is widely used has a long safety history for use in pregnancy and during anesthesia for caesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ondansetron | Experimental | Drug: ondansetronondansetron 8 mg IV will be administered prior to placement of the spinal anesthesia |
| Placebo | Placebo comparator | Drug: placeboOndansetron 8 mg IV or Placebo will be administered prior to placement of the spinal anesthestic |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Elective Caesarean section
- Consent to be in the study
- Age 18-45
- ASA 1 or 2
Key exclusion criteria (7 listed)
- Patient refusal
- Patients with known allergy to ondansetron will be excluded
- Contraindications to spinal anesthetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ondansetronAlso: epiduralOndansetron 8mg IV or placebo will be administered prior to placement of the spinal anesthetic | Drug | ondansetron |
| placeboAlso: epiduralplacebo or ondansetron 8mg IV will be administered prior to placement of the spinal anesthetic | Drug | Placebo |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability"
Time frame: day 1
hypotension \& bradycardia will be recorded from the placement of the spinal through the end of surgical c-section
5 secondary outcomes
dosage of vasopressors administered
Time frame: day one
number of episodes of nausea
Time frame: 24 hours after surgery
occurrence & intensity of itching
Time frame: 24 hours after surgery
pain scores reported by the patient
Time frame: 24 hours after surgery
dosage of anticholinergics administered
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Background: PubMed 12972749Hawkins JL. Anesthesia-related maternal mortality. Clin Obstet Gynecol. 2003 Sep;46(3):679-87. doi: 10.1097/00003081-200309000-00020. No abstract available.
- Background: PubMed 17525583Mhyre JM, Riesner MN, Polley LS, Naughton NN. A series of anesthesia-related maternal deaths in Michigan, 1985-2003. Anesthesiology. 2007 Jun;106(6):1096-104. doi: 10.1097/01.anes.0000267592.34626.6b.
- Background: PubMed 15220784Lee LA, Posner KL, Domino KB, Caplan RA, Cheney FW. Injuries associated with regional anesthesia in the 1980s and 1990s: a closed claims analysis. Anesthesiology. 2004 Jul;101(1):143-52. doi: 10.1097/00000542-200407000-00023.
- Background: PubMed 11388543Liu SS, McDonald SB. Current issues in spinal anesthesia. Anesthesiology. 2001 May;94(5):888-906. doi: 10.1097/00000542-200105000-00030. No abstract available.
- Background: PubMed 7547039Jackson R, Reid JA, Thorburn J. Volume preloading is not essential to prevent spinal-induced hypotension at caesarean section. Br J Anaesth. 1995 Sep;75(3):262-5. doi: 10.1093/bja/75.3.262.
- Background: PubMed 8164943Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994 May;83(5 Pt 1):774-88.
- Background: PubMed 8063445Rout CC, Rocke DA. Prevention of hypotension following spinal anesthesia for cesarean section. Int Anesthesiol Clin. 1994 Spring;32(2):117-35. No abstract available.
- Background: PubMed 7191222Mathru M, Rao TL, Kartha RK, Shanmugham M, Jacobs HK. Intravenous albumin administration for prevention of spinal hypotension during cesarean section. Anesth Analg. 1980 Sep;59(9):655-8.
- Background: PubMed 16095463Dahlgren G, Granath F, Pregner K, Rosblad PG, Wessel H, Irestedt L. Colloid vs. crystalloid preloading to prevent maternal hypotension during spinal anesthesia for elective cesarean section. Acta Anaesthesiol Scand. 2005 Sep;49(8):1200-6. doi: 10.1111/j.1399-6576.2005.00730.x.
- Background: PubMed 10598596Ueyama H, He YL, Tanigami H, Mashimo T, Yoshiya I. Effects of crystalloid and colloid preload on blood volume in the parturient undergoing spinal anesthesia for elective Cesarean section. Anesthesiology. 1999 Dec;91(6):1571-6. doi: 10.1097/00000542-199912000-00006.
- Background: PubMed 7574020Riley ET, Cohen SE, Rubenstein AJ, Flanagan B. Prevention of hypotension after spinal anesthesia for cesarean section: six percent hetastarch versus lactated Ringer's solution. Anesth Analg. 1995 Oct;81(4):838-42. doi: 10.1097/00000539-199510000-00031.
- Background: PubMed 12717149Campagna JA, Carter C. Clinical relevance of the Bezold-Jarisch reflex. Anesthesiology. 2003 May;98(5):1250-60. doi: 10.1097/00000542-200305000-00030. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Hackworth, MD principal investigator
University of Virginia Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ondansetron in people with Hypotension and Pregnancy, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability" (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01414777, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.